K120204 is an FDA 510(k) clearance for the REPROCESSED FEMORAL COMPRESSION DEVICE. This device is classified as a Clamp, Vascular, Reprocessed (Class II - Special Controls, product code NMF).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 3, 2012, 71 days after receiving the submission on January 23, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K120204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2012 |
| Decision Date | April 03, 2012 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NMF — Clamp, Vascular, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |
| Definition | Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |